Irritable Bowel Syndrome

FDA approves restricted marketing of Lotronex

Published in Medical Letter on the CDC and FDA, July 7th, 2002

The U.S. Food and Drug Administration (FDA) has approval a supplemental new drug application (sNDA) that permits marketing of Lotronex (alosetron hydrochloride) with restrictions.

The manufacturer of the drug, GlaxoSmithKline, will be implementing a risk management program including a prescribing program to enroll physicians who wish to prescribe Lotronex. The drug's indication has been narrowed to be only for treatment of women with severe, diarrhea-predominant irritable bowel syndrome (IBS) who have failed to respond to conventional IBS therapy. Limiting the use of Lotronex to this severely affected population is intended to maximize the benefit-to-risk...

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Source: Medical Letter on the CDC and FDA (2002-07-07)

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